Ocular implant with stiffness qualities, methods of implantation and system

ABSTRACT

Described herein are devices and methods for treating eye conditions. Described is an ocular implant including an elongate member having an internal lumen forming a flow pathway, at least one inflow port communicating with the flow pathway, and at least one outflow port communicating with the flow pathway. The elongate member is adapted to be positioned in the eye such that at least one inflow port communicates with the anterior chamber, at least one outflow port communicates with the suprachoroidal space to provide a fluid pathway between the anterior chamber and the suprachoroidal space when the elongate member is implanted in the eye. The elongate member has a wall material imparting a stiffness to the elongate member. The stiffness is selected such that after implantation the elongate member deforms eye tissue surrounding the suprachoroidal space forming a tented volume.

REFERENCE TO PRIORITY DOCUMENTS

This application claims priority benefit under 35 U.S.C. 119(e) ofco-pending U.S. Provisional Patent Application Ser. Nos. 61/147,988,filed Jan. 28, 2009, entitled “Ocular Implant with Stiffness Qualities,”61/222,054, filed Jun. 30, 2009, entitled “Ocular Device ImplantationMethod and System,” and 61/246,017, filed Sep. 25, 2009, entitled“Ocular Implant to Reduce Aqueous Humor Production.” The disclosures ofthe Provisional Patent Applications are hereby incorporated by referencein their entirety.

BACKGROUND

This disclosure relates generally to methods and devices for use intreating glaucoma. In particular, this disclosure relates to a devicethat is implantable in the eye to form a fluid passageway between theanterior chamber and the suprachoroidal space wherein the device has arelative stiffness that causes a portion of the suprachoroidal space toachieve desired shape when the implant is deployed. The implantsdescribed herein can also affect the production of aqueous humor by theciliary body.

The mechanisms that cause glaucoma are not completely known. It is knownthat glaucoma results in abnormally high pressure in the eye, whichleads to optic nerve damage. Over time, the increased pressure can causedamage to the optic nerve, which can lead to blindness. Treatmentstrategies have focused on keeping the intraocular pressure down inorder to preserve as much vision as possible over the remainder of thepatient's life.

Past treatment includes the use of drugs that lower intraocular pressurethrough various mechanisms. The glaucoma drug market is an approximatetwo billion dollar market. The large market is mostly due to the factthat there are not any effective surgical alternatives that are longlasting and complication-free. Unfortunately, drug treatments as well assurgical treatments that are available need much improvement, as theycan cause adverse side effects and often fail to adequately controlintraocular pressure. Moreover, patients are often lackadaisical infollowing proper drug treatment regimens, resulting in a lack ofcompliance and further symptom progression.

With respect to surgical procedures, one way to treat glaucoma is toimplant a drainage device in the eye. The drainage device functions todrain aqueous humor from the anterior chamber and thereby reduce theintraocular pressure. The drainage device is typically implanted usingan invasive surgical procedure. Pursuant to one such procedure, a flapis surgically formed in the sclera. The flap is folded back to form asmall cavity and the drainage device is inserted into the eye throughthe flap. Such a procedure can be quite traumatic as the implants arelarge and can result in various adverse events such as infections andscarring, leading to the need to re-operate.

Current devices and procedures for treating glaucoma have disadvantagesand only moderate success rates. The procedures are very traumatic tothe eye and also require highly accurate surgical skills, such as toproperly place the drainage device in a proper location. In addition,the devices that drain fluid from the anterior chamber to asubconjunctival bleb beneath a scleral flap are prone to infection, andcan occlude and cease working. This can require re-operation to removethe device and place another one, or can result in further surgeries. Inview of the foregoing, there is a need for improved devices and methodsfor the treatment of glaucoma.

SUMMARY

There is a need for improved devices and methods for the treatment ofeye diseases such as glaucoma. In particular, there is a need forsimplified, low profile devices for the treatment of glaucoma and otherdiseases using a delivery system that uses a minimally-invasiveprocedure.

In an embodiment described herein is an ocular implant including anelongate member having an internal lumen forming a flow pathway, atleast one inflow port communicating with the flow pathway, and at leastone outflow port communicating with the flow pathway. The elongatemember is adapted to be positioned in the eye such that at least oneinflow port communicates with the anterior chamber, at least one outflowport communicates with the suprachoroidal space to provide a fluidpathway between the anterior chamber and the suprachoroidal space whenthe elongate member is implanted in the eye. The elongate member has awall material imparting a stiffness to the elongate member. Thestiffness is selected such that after implantation the elongate memberdeforms eye tissue surrounding the suprachoroidal space forming a tentedvolume.

The stiffness of the elongate member can be greater than a stiffness ofthe eye tissue surrounding the suprachoroidal space. The elongate membercan form a chord relative to a curvature of the suprachoroidal space.The eye tissue surrounding the suprachoroidal space can include an outertissue shell having a first boundary and a first curvature and an innertissue shell having a second boundary and a second curvature, whereinthe first curvature and the second curvature form a ratio. The stiffnessof the elongate member can change the ratio between the first curvatureand the second curvature. The elongate member can be curved such that itintersects, but does not conform to the first or second curvatures whenimplanted.

The wall material can have a Young's modulus that is less than 30,000pounds per square inch. The wall material can have a Young's modulusthat is between about 30,000 pounds per square inch and 70,000 poundsper square inch. The wall material can have a Young's modulus that isapproximately 200,000 pounds per square inch. The wall material can havea Young's modulus that is less than or equal to 40,000,000 pounds persquare inch. The elongate member can have an inner diameter of about0.012 inch and an outer diameter of about 0.015 inch. The elongatemember can have a length in the range of about 0.250 inch to about 0.300inch.

Also disclosed are methods of implanting an ocular device into the eye.In an embodiment, the method includes forming an incision in the corneaof the eye; loading onto a delivery device an implant having a fluidpassageway and a wall material imparting a stiffness to the implant;inserting the implant loaded on the delivery device through the incisioninto the anterior chamber of the eye; passing the implant along apathway from the anterior chamber into the suprachoroidal space;positioning at least a portion of the implant in the suprachoroidalspace such that a first portion of the fluid passageway communicateswith the anterior chamber and a second portion of the fluid passagewaycommunicates with the suprachoroidal space to provide a fluid passagewaybetween the suprachoroidal space and the anterior chamber; and releasingthe implant from the delivery device such that the implant achieves apredetermined shape within the suprachoroidal space and forms a chordrelative to a curvature of the suprachoroidal space.The chord can bestraight or the chord can be curved. The stiffness of the implant can begreater than a stiffness of adjacent eye tissue.

In another embodiment the method of treating an eye includes forming anincision in the cornea of the eye; inserting an implant through theincision into the anterior chamber of the eye wherein the implantincludes a fluid passageway; passing the implant along a pathway fromthe anterior chamber into the suprachoroidal space; positioning theimplant such that a first portion of the fluid passageway communicateswith the anterior chamber and a second portion of the fluid passagewaycommunicates with the suprachoroidal space to provide a fluid passagewaybetween the suprachoroidal space and the anterior chamber; and applyinga force on the ciliary body with the implant so as to reduce aqueousoutflow from the ciliary body.

Applying a force on the ciliary body with the implant can elicit anincrease in prostaglandin production by the ciliary body. Applying aforce on the ciliary body with the implant can include displacing atleast a portion of the ciliary body. Applying a force on the ciliarybody with the implant does not necessarily displace the ciliary body.

Other features and advantages should be apparent from the followingdescription of various embodiments, which illustrate, by way of example,the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional, perspective view of a portion of the eyeshowing the anterior and posterior chambers of the eye;

FIG. 2 is a cross-sectional view of a human eye;

FIG. 3 shows an embodiment of an implant;

FIG. 4 shows relative shapes of the implant and the suprachoroidalspace;

FIG. 5A shows an exemplary delivery system that can be used to deliverthe implant into the eye;

FIG. 5B shows another embodiment of a delivery system that can be usedto deliver an implant into the eye;

FIG. 5C and 5D show the delivery system of FIG. 5B during actuation;

FIG. 6A-6D show an exemplary mechanism for delivering an implant;

FIG. 6E is a cross-sectional view of an embodiment of a delivery system;

FIG. 6F is a cross-sectional view of the delivery system of FIG. 6Ataken along line F-F;

FIG. 6G shows a cross-sectional view of the eye and a viewing lens;

FIG. 7 shows a schematic of the fiber optic visualization and deliverysystem positioned for penetration into the eye;

FIG. 8 shows an enlarged view of a portion of the anterior region of theeye in cross-section;

FIG. 9 shows the implant positioned within the suprachoroidal space;

FIGS. 10A-10D show other implants that reduces aqueous humor production.

It should be appreciated that the drawings herein are exemplary only andare not meant to be to scale.

DETAILED DESCRIPTION

There is a need for improved methods and devices for the treatment ofeye diseases. Disclosed herein are low profile, simplified devices thatcan be used in the eye for the treatment of glaucoma and other eyediseases. The devices can be placed in the eye such that the implantprovides a fluid pathway for the flow or drainage of aqueous humor fromthe anterior chamber to the suprachoroidal space. The devices describedherein are designed to enhance aqueous flow through the normal outflowsystem of the eye with minimal to no complications.

There is also a need for low profile, simplified delivery devices todeliver an implant that can gently and bluntly dissect between tissuemargins or tissue layer boundaries, for example, between the iris rootand the scleral spur or the iris root part of the ciliary body and thescleral spur into the supraciliary space and then, further on, betweenthe sclera and the choroid into the suprachoroidal space in the eye. Thedevices described herein can be implanted in the eye using a deliverysystem that uses a minimally-invasive procedure and can penetratecertain tissues and separate tissue boundaries while avoid penetratingcertain other tissues. Any of the procedures and devices describedherein can be performed in conjunction with other therapeuticprocedures, such as laser iridotomy, laser iridoplasty, andgoniosynechialysis (a cyclodialysis procedure).

Described herein also are devices, systems and methods for the treatmentof eye diseases such as glaucoma that cause a reduction in aqueous humorproduction. Aqueous humor is generally produced by ciliary body cells.Implanting a device that can impose a force such as a radial force onstructures in the eye such as the ciliary body aqueous humor productionby these cells can be reduced resulting in a decrease in intraocularpressure.

FIG. 1 is a cross-sectional, perspective view of a portion of the eyeshowing the anterior and posterior chambers of the eye. A schematicrepresentation of an implant 105 is positioned inside the eye such thata proximal end 110 is located in the anterior chamber 115 and a distalend 120 extends to a region of the eye that is between the ciliary bodyand the sclera. Alternatively, the distal end 120 can extend to a regionof the eye that is posterior to the ciliary body, such as between thechoroid and the sclera. The suprachoroidal space (sometimes referred toas the perichoroidal space) can include the region between the scleraand the choroid. The suprachoroidal space can also include the regionbetween the sclera and the ciliary body. In this regard, the region ofthe suprachoroidal space between the sclera and the ciliary body maysometimes be referred to as the supraciliary space. The implantdescribed herein is not necessarily positioned between the choroid andthe sclera. The implant 105 can be positioned at least partially betweenthe ciliary body and the sclera or it can be at least partiallypositioned between the sclera and the choroid. In any event, the implant105 can provide a fluid pathway for flow of aqueous humor through oralong the implant between the anterior chamber and the suprachoroidalspace.

In an embodiment, the implant 105 can be an elongate element having oneor more internal lumens through which aqueous humor can flow from theanterior chamber 115 into the suprachoroidal space. The implant 105 canhave a substantially uniform diameter along its entire length, althoughthe shape of the implant 105 can vary along its length (either before orafter insertion of the implant), as described below. Moreover, theimplant 105 can have various cross-sectional shapes (such as circular,oval or rectangular shape) and can vary in cross-sectional shape movingalong its length. The cross-sectional shape can be selected tofacilitate easy insertion into the eye. The following applicationsdescribe exemplary implants and are incorporated by reference in theirentirety: U.S. Patent Publication Nos. 2007-0191863 and 2009-0182421.

At least a portion of the implant can be formed of a structure having astiffness that causes the implant 105 to form a chord (either straight,curved, or curvlinear) relative to the natural-state curvature of thesuprachoroidal space, as described in detail below. That is, the implantcan define a line that intersects at least two points along a curve thatconforms to the natural curvature of the suprachoroidal space if theimplant were not present. The implant 105 can have a stiffness that isgreater than the stiffness of adjacent eye tissue (e.g., the choroid andthe sclera or the ciliary body and sclera) such that the implant 105deforms the eye tissue and forms a chord relative to the curvature ofthe suprachoroidal space when implanted in the eye. The presence of theimplant 105 can cause the suprachoroidal space to achieve a geometrythat produces a tented volume within the suprachoroidal space.

Eye Anatomy and Glaucoma

FIG. 2 is a cross-sectional view of a portion of the human eye. The eyeis generally spherical and is covered on the outside by the sclera S.The retina lines the inside posterior half of the eye. The retinaregisters the light and sends signals to the brain via the optic nerve.The bulk of the eye is filled and supported by the vitreous body, aclear, jelly-like substance. The elastic lens L is located near thefront of the eye. The lens L provides adjustment of focus and issuspended within a capsular bag from the ciliary body CB, which containsthe muscles that change the focal length of the lens. A volume in frontof the lens L is divided into two by the iris I, which controls theaperture of the lens and the amount of light striking the retina. Thepupil is a hole in the center of the iris I through which light passes.The volume between the iris I and the lens L is the posterior chamberPC. The volume between the iris I and the cornea is the anterior chamberAC. Both chambers are filled with a clear liquid known as aqueous humor.

The ciliary body CB continuously forms aqueous humor in the posteriorchamber PC by secretion from the blood vessels. The aqueous humor flowsaround the lens L and iris I into the anterior chamber and exits the eyethrough the trabecular meshwork TM, a sieve-like structure situated atthe corner of the iris I and the wall of the eye (the corner is known asthe iridocorneal angle). Some of the aqueous humor filters through thetrabecular meshwork near the iris root into Schlemm's canal, a smallchannel that drains into the ocular veins. A smaller portion rejoins thevenous circulation after passing through the ciliary body and eventuallythrough the sclera (the uveoscleral route).

Glaucoma is a disease wherein the aqueous humor builds up within theeye. In a healthy eye, the ciliary processes secrete aqueous humor,which then passes through the angle between the cornea and the iris.Glaucoma appears to be the result of clogging in the trabecularmeshwork. The clogging can be caused by the exfoliation of cells orother debris. When the aqueous humor does not drain properly from theclogged meshwork, it builds up and causes increased pressure in the eye,particularly on the blood vessels that lead to the optic nerve. The highpressure on the blood vessels can result in death of retinal ganglioncells and eventual blindness.

Closed angle (acute) glaucoma can occur in people who were born with anarrow angle between the iris and the cornea (the anterior chamberangle). This is more common in people who are farsighted (they seeobjects in the distance better than those which are close up). The iriscan slip forward and suddenly close off the exit of aqueous humor, and asudden increase in pressure within the eye follows.

Open angle (chronic) glaucoma is by far the most common type ofglaucoma. In open angle glaucoma, the iris does not block the drainageangle as it does in acute glaucoma. Instead, the fluid outlet channelswithin the wall of the eye gradually narrow with time. The diseaseusually affects both eyes, and over a period of years the consistentlyelevated pressure slowly damages the optic nerve.

Implant

FIG. 3 shows a first embodiment of an implant 105. The implant 105 canbe an elongate member having a proximal end, a distal end, and astructure that permits fluid (such as aqueous humor) to flow along thelength of the implant such as through or around the implant from theanterior chamber to the suprachoroidal space. As mentioned above, theproximal end of the implant 105 is positioned in the anterior chamberand the distal end of the implant can extend to a region of the eye thatis between the ciliary body and the sclera. The distal end of theimplant can also extend to a region of the eye that is posterior to theciliary body, such as between the choroid and the sclera. Thesuprachoroidal space can include the region between the sclera and thechoroid as well as the region between the sclera and the ciliary body.The implant 105 can provide a fluid pathway for communication of aqueoushumor between the anterior chamber and the suprachoroidal space.

In the embodiment of FIG. 3, the implant 105 can include at least oneinternal lumen 110 having at least one opening 115 for ingress of fluid(such as aqueous humor from the anterior chamber) and at least oneopening 120 for egress of fluid into the suprachoroidal space. Theimplant 105 can include various arrangements of openings 125 thatcommunicate with the lumen(s) 110. The openings 125 in the implant 105can be filled with a material or mixture of materials, such as a spongematerial, to prevent unwanted tissue in-growth into the openings 125when the implant 105 is positioned in the eye. The sponge material canalso be filled with a drug or other material that leaches into the eyeover time upon implantation. During delivery of the implant 105, theopenings 125 can be positioned so as to align with predeterminedanatomical structures of the eye. For example, one or more openings 125can align with the suprachoroidal space to permit the flow of aqueoushumor into the suprachoroidal space, while another set of openings 125can align with structures proximal to the suprachoroidal space, such asstructures in the ciliary body or the anterior chamber of the eye.

The internal lumen 110 can serve as a passageway for the flow of aqueoushumor through the implant 105 directly from the anterior chamber to thesuprachoroidal space. In addition, the internal lumen 110 can be used tomount the implant 105 onto a delivery system, as described below. Theinternal lumen 110 can also be used as a pathway for flowing irrigationfluid into the eye generally for flushing or to maintain pressure in theanterior chamber. In the embodiment of FIG. 3, the implant 105 can havea substantially uniform diameter along its entire length, although theshape of the implant 105 can vary along its length (either before orafter insertion of the implant). Moreover, the implant 105 can havevarious cross-sectional shapes (such as a, circular, oval or rectangularshape) and can vary in cross-sectional shape moving along its length.The cross-sectional shape can be selected to facilitate easy insertioninto the eye.

FIG. 3 shows an embodiment of the implant 105 having a tubular orpartially tubular structure. The implant 105 has a proximal region 305and a distal region 315. In an embodiment, the proximal region 305 has agenerally tubular shape with a collar 325. The collar 325 is shown inphantom lines to indicate that the collar 325 is optional. The collar325 can be formed of the same material as the rest of the implant 105 ora different material. The collar 325 can have various shapes including afunnel shape such that the collar 325 provides a relatively wide openingthat communicates with the internal lumen of the implant 105.

As illustrated schematically in FIG. 4, when implanted in the eye theimplant 105 can form a dissection plane within or near thesuprachoroidal space. The dissection plane can be straight or it can becurved as the dissection plane is being formed. At least a portion ofthe suprachoroidal space can be described as the space between twocurved shells: a first, outer shell including the scleral tissue and asecond, inner shell including the choroidal tissue. Alternatively, thefirst, outer shell can include the scleral tissue and the second, innershell can include the ciliary body tissue. The shells can abut oneanother in that the inner surface of the sclera abuts the outer surfaceof the choroid (or ciliary body) with the suprachoroidal space being avirtual space that exists when the sclera is separated from the choroid(or ciliary body). The sclera has a tougher texture than the choroid orciliary body. The implant 105 can have a stiffness such that itspresence in or near the suprachoroidal space can increase or decreaseratios of curvature of one or both of the shells by pushing against thetough outer shell and/or the fragile inner shell. If the dissectionplane is curved, the dissection plane can have a curvature that willfollow a dissecting wire that performs the dissection or that isgoverned by the shape and/or stiffness of the implant positioned in thedissection plane. The curvature can be different from the curvature ofthe suprachoroidal space when the implant is implanted in the eye. Thus,the implant can form a straight or curved chord relative to the naturalcurvature of the suprachoroidal space if the implant were not present inthe suprachoroidal space.

FIG. 4 shows a curve S (in solid line) that represents the naturalcurvature of the suprachoroidal space when the implant is not present.The implant 105 (represented by a dashed line) can be a straight implant(as shown in FIG. 4) or a curved implant that intersects the naturalcurvature S but does not conform to the natural curvature whenimplanted. The implant 105 can have a relative stiffness such that, whenimplanted, the implant 105 can deform at least a portion of the tissueadjacent the suprachoroidal space to take on a shape that is differentthan the natural curvature. In this manner, the implant 105 can form atent or volume between the tissue boundaries (formed by the sclera andchoroid) of the suprachoroidal space that does not exist naturally.

The implant 105 can have structural properties that cause the implant tointerfere with and/or resist the natural curvature of the suprachoroidalspace when implanted in the eye. In this regard, the implant 105 canhave an effective or extrinsic Young's modulus (relative to the Young'smodulus of the tissue boundary of the suprachoroidal space) that causesthe implant to interfere with and locally change the curvature of theboundary between the sclera and the choroid when implanted in the eye.The effective modulus of the implant can depend upon the intrinsicmodulus (or Young's modulus in this case), the shape and thickness ofthe implant. As mentioned above, the implant 105, when implanted, doesnot necessarily extend into a region of the suprachoroidal space that isbetween the sclera and the choroid. The implant can be positionedbetween the ciliary body and the sclera (within the supraciliary space)but still communicate with the suprachoroidal space. The implant 105 canbe made of a material that has the requisite stiffness, or the implantcan have structural properties, such as thickness or length, thatachieve the requisite stiffness and deformation of the normal curvatureof the sclera-suprachoroid boundary.

In an embodiment, a portion of the implant can be made of a materialthat has a Young's modulus that is less than 3,000 pounds per squareinch (PSI). In another embodiment, the Young's modulus is greater than30,000 psi. In another embodiment, the Young's modulus is between 30,000psi and 70,000 psi. In another embodiment, the Young's modulus is 70,000psi to 200,000 psi. In another embodiment, the Young's modulus is in therange of 100,000 psi to 200,000 psi. In another embodiment, the Young'smodulus is approximately 200,000 psi. In another embodiment, the Young'smodulus is less than or equal to 40,000,000 psi. It should beappreciated that the aforementioned values are exemplary andnon-limiting. As mentioned above, the effective modulus of the implantdepends upon intrinsic modulus (or Young's modulus in this case), shapeand thickness of the implant. Therefore, if the modulus of the implantis below 30,000 psi, the dimensions of the implant such as materialshape and thickness can be sufficient to maintain the effective modulusof the implant in order to overcome the bending modulus of one or moreof the surrounding tissues.

In an embodiment, the implant 105 can have a column strength sufficientto permit the implant 105 to be inserted into suprachoroidal space suchthat the distal tip of the implant 105 tunnels through the eye tissue(such as the ciliary body) without structural collapse or structuraldegradation of the implant 105. In addition, the surface of the innerlumen can be sufficiently smooth relative to the delivery device(described in detail below) to permit the implant 105 to slide off ofthe delivery device during the delivery process. In an embodiment, thecolumn strength can be sufficient to permit the implant to tunnelthrough the eye tissue into the suprachoroidal space without anystructural support from an additional structure such as a deliverydevice.

The implant 105 can be made of various materials, including, forexample, polyimide, Nitinol, platinum, stainless steel, molybdenum, orany other suitable polymer, metal, metal alloy, or ceramic biocompatiblematerial or combinations thereof. Other materials of manufacture ormaterials with which the shunt can be coated or manufactured entirelyinclude Silicone, PTFE, ePTFE, differential fluoropolymer, FEP, FEPlaminated into nodes of ePTFE, silver coatings (such as via a CVDprocess), gold, prolene/polyolefins, polypropylene, poly(methylmethacrylate) (PMMA), acrylic, PolyEthylene Terephthalate (PET),Polyethylene (PE), PLLA, and parylene. The implant 105 can be reinforcedwith polymer, Nitinol, or stainless steel braid or coiling or can be aco-extruded or laminated tube with one or more materials that provideacceptable flexibility and hoop strength for adequate lumen support anddrainage through the lumen. The shunt can alternately be manufactured ofnylon (polyamide), PEEK, polysulfone, polyamideimides (PAI), polyetherblock amides (Pebax), polyurethanes, thermoplastic elastomers (Kraton,etc), and liquid crystal polymers.

Any of the embodiments of the implant 105 described herein can be coatedon its inner or outer surface with one or more drugs or other materials,wherein the drug or material maintains the patency of the lumen orencourages in-growth of tissue to assist with retention of the implantwithin the eye or to prevent leakage around the implant. The drug canalso be used for disease treatment. The implant can also be coated onits inner or outer surface with a therapeutic agent, such as a steroid,an antibiotic, an anti-inflammatory agent, an anti-coagulant, ananti-glaucomatous agent, an anti-proliferative, or any combinationthereof. The drug or therapeutic agent can be applied in a number ofways as is known in the art. Also the drug can be embedded in anotherpolymer (nonabsorbable or bioabsorbable) that is coated on the implant.

The implant can also be coated or layered with a material that expandsoutward once the shunt has been placed in the eye. The expanded materialfills any voids that are positioned around the shunt. Such materialsinclude, for example, hydrogels, foams, lyophilized collagen, or anymaterial that gels, swells, or otherwise expands upon contact with bodyfluids.

The implant can also be covered or coated with a material (such aspolyester, ePTFE(also known as GORETEX.RTM.), PTFE that provides asurface to promote healing of the shunt into the surrounding tissue. Inorder to maintain a low profile, well-known sputtering techniques can beemployed to coat the shunt. Such a low profile coating would accomplisha possible goal of preventing migration while still allowing easyremoval if desired.

In an embodiment, the implant can have an inner diameter in the range ofabout 0.002″ to about 0.050″, an outer diameter in the range of about0.006″ to about 0.100″, and a length in the range of about 0.100″ toabout 1.50″. In another embodiment, the implant has an inner diameter inthe range of about 0.008″ to about 0.025″. In another embodiment, theimplant has an inner diameter in the range of about 0.010″ to about0.012″. In another embodiment, the implant has an outer diameter in therange of about 0.012″ to about 0.075″.

In another embodiment, the implant has an outer diameter in the range ofabout 0.025″ to about 0.050″. In another embodiment, the implant has alength in the range of about 0.125″ to about 0.75″. In anotherembodiment, the implant has a length in the range of about 0.25″ toabout 0.50″. In another embodiment, the implant has an inner diameter ofabout 0.012″, an outer diameter of about 0.020″ and a length of about0.25″.

The implant can also have visual markers along its length to assist theuser in positioning the desired portion of the implant within theanterior chamber. Further, the implant 105 and/or delivery system canemploy alignment marks, tabs, slots or other features that allow theuser to know alignment of the implant with respect to the deliverydevice. The implant 105 can include one or more features that aid inproperly positioning the implant 105 in the eye. For example, theimplant can have one or more visual, tomographic, echogenic, orradiopaque markers that can be used to aid in placement using any of thedevices referenced above tuned to its applicable marker system. In usingthe markers to properly place the implant, the implant is inserted inthe suprachoroidal space, until the marker is aligned with a relevantanatomic structure, for example, visually identifying a marker on theanterior chamber portion of the implant that aligns with the trabecularmeshwork, or scleral spur, such that an appropriate length of theimplant remains in the anterior chamber. Under ultrasound, an echogenicmarker can signal the placement of the device within the suprachoroidalspace. Any marker can be placed anywhere on the device to providesensory feedback to the user on real-time placement, confirmation ofplacement or during patient follow up. Other structural features aredescribed below.

Implant Delivery System

In an embodiment, a delivery system is used to deliver an implant 105into the eye such that the implant 105 provides fluid communicationbetween the anterior chamber and the suprachoroidal space. FIG. 5A showsan embodiment of a delivery system 305 that can be used to deliver theimplant 105 into the eye. FIG. 5B shows another embodiment of a deliverysystem 305 that can be used to deliver the implant 105 into the eye. Itshould be appreciated that these delivery systems 305 are forillustration and that variations in the structure, shape and actuationof the delivery system 305 are possible.

The delivery system 305 generally includes a proximal handle component310 and a distal delivery component 320. The proximal handle component310 can include an actuator 420 to control the release of an implantfrom the delivery component 320 into the target location in the eye. Theproximal handle component 310 also can include a channel 425 forinsertion of an internal visualization system, such as a fiber opticimage bundle 415, as in the embodiment of FIG. 5B. Such a deliverysystem having an internal visualization system need not be used inconjunction with a gonioscope or viewing lens.

The delivery component 320 includes an elongate applier 515 that caninsert longitudinally through the internal lumen of the implant 105 anda sheath 510 that can be positioned axially over the applier 515. Thesheath 510 aids in the release of the implant 105 from the deliverycomponent 320 into the target location in the eye. As best shown in FIG.5C and 5D, the actuator 420 can be used to control the applier 515and/or the sheath 510. For example, the sheath 510 can be urged in adistal direction relative to the applier 515 to push the implant 105 offthe distal end of the applier 515. Alternately, the sheath 510 can befixed relative to the handle component 310. In this embodiment, thesheath 510 can act as a stopper that impedes the implant 105 from movingin a proximal direction as the applier 515 is withdrawn proximally fromthe implant 105 upon actuation of the actuator 420. In a first stateshown in FIG. 5C, the applier 515 can be extended distally relative tothe sheath 310. Movement of the actuator 420, such as in the proximaldirection, can cause the applier 515 to slide proximally into the sheath510 as shown in FIG. 5D. This effectively pushes the implant 105 off thedistal end of the applier 515 and releases the implant 105 in acontrolled fashion such that the target positioning of the implant 105within the suprachoroidal space is maintained. The delivery device 305can also incorporate a delivery channel within which the implant 105 canreside and a pusher that can push the implant out from the deliverychannel during implantation.

Internal Implant Retention Layer

The outer diameter of the applier 515 is generally smaller than theinner diameter of the implant 105 (i.e. the fluid channel) such that theimplant 105 can be loaded onto the applier 515. In some instances, theouter diameter of the applier 515 can be significantly smaller therebycreating a gap G between the applier 515 and the implant 105 (see FIG.6E). This gap G leaves room for adding a retention layer 512 or aretention coating to the delivery component 320 (see FIG. 6F). Theretention layer 512 can retain the implant 105 on the applier 515 duringblunt dissection and implantation to prevent the implant 105 frominadvertently falling off the applier 515 until it is delivered to thedesired target location within the eye. An advantage of a retentionlayer 512 between the implant and the applier is the very low profile ofthe delivery system 305 and a user's improved ability to visualize eachstep of implantation. Retention layers added externally around theimplant, in contrast, significantly increase the profile of the deliverydevice and negatively impact the user's ability to visualize the stepsof delivery. External retention layers can also increase the size of theincision needed to insert the delivery device.

FIGS. 6A-6D show cross-sectional schematic views of an implant 105mounted on a delivery portion 320 inserted from the anterior chamberinto the suprachoroidal space. The figures show an implant 105 mountedon the end of an applier 515, a sheath 510 sized and shaped to receiveor abut a portion of the proximal end 125 of the implant 105, and aretention layer 512 providing an interference fit between the implant105 and the applier 515. In this embodiment upon actuation the applier515 slides in the proximal direction (arrow P) into the sheath 510. Theproximal end 125 of the implant 105 abuts the distal edge of the sheath510 to prevent the implant 105 from sliding in the proximal direction.This effectively pushes the implant 105 off the distal end of theapplier 515 and controllably releases the implant 105 into thesuprachoroidal space SC. The retention layer 512 moves with the applier515 such that the applier 515 and retention layer 512 are fullywithdrawn into the sheath 510. It should be appreciated that the sheath510 can also advanced distally over the applier 515 upon actuation todeliver the implant 105 into the suprachoroidal space.

The retention layer 512 can include, for example, a sleeve such as ashrink-to-fit tube that can be inserted over the applier 515. Theretention layer 512 can also be inserted through the fluid pathway ofthe implant 105. The retention layer 512 can also include a coating ofmaterial, for example on the outer diameter of the applier 515 or on theinner diameter of the implant 105. The retention layer 512 can alsoserve to prevent tissue from jamming into the gap G between the applier515 and implant 105, for example during insertion of the device throughthe iris root or the ciliary body.

The retention layer 512 can be a variety of materials. In an embodiment,the retention layer 512 can be a generally soft, elastomeric, compliantpolymer. For example, the material of the retention layer 512 caninclude silicone, thermoplastic elastomers (HYTREL, RATON, PEBAX),certain polyolefin or polyolefin blends, elastomeric alloys,polyurethanes, thermoplastic copolyester, polyether block amides,polyamides (such as Nylon), block copolymer polyurethanes (such asLYCRA). Some other exemplary materials include fluoropolymer (such asFEP and PVDF), FEP laminated into nodes of ePTFE, acrylic, low glasstransition temperature acrylics, and hydrogels. It should also beappreciated that stiffer polymers can be made to be more compliant byincorporating air or void volumes into their bulk, for example, PTFE andexpanded PTFE.

Dissection Dynamics of Applier

As described above, the delivery component 320 can include an elongateapplier 515. The shape, structure, materials and material properties ofthe applier 515 are selected to optimize the gentle, blunt dissectionbetween the tissue boundaries adjacent to the inner wall of the scleraand formation of the suprachoroidal space. The applier 515 can have across-sectional size and shape that complements the cross-sectionalshape of the internal lumen of the implant 105 through which the applier515 extends when the implant 105 is loaded thereon.

A variety of parameters including the shape, material, materialproperties, diameter, flexibility, compliance, pre-curvature and tipshape of the applier 515 can impact the performance of the applier 515during gentle, blunt tissue dissection. The applier 515 desirablypenetrates certain tissues while avoids penetration of other tissues.For example, it is desirable that the applier 515 be capable ofpenetrating the iris root or the ciliary body. The same applier 515would beneficially be incapable of penetrating the scleral spur or innerwall of the sclera such that it can gently dissect between the tissueboundaries adjacent to the inner wall of the sclera.

The shape of the applier 515 along its long axis can be straight (asshown in FIG. 5B) or it can be can be curved along all or a portion ofits length (as shown in FIGS. 5A) in order to facilitate properplacement. In the case of the curved applier 515, the radius ofcurvature can vary. For example, the applier 515 can have a radius ofcurvature of 3 mm to 50 mm and the curve can cover from 0 degrees to 180degrees. In one embodiment, the applier 515 has a radius of curvaturethat corresponds to or complements the radius of curvature of a regionof the eye, such as the inner wall of the sclera. For example, theradius of curvature can be approximately 11-12 mm. Moreover, the radiusof curvature can vary moving along the length of the applier 515. Therecan also be means to vary the radius of curvature of portions of theapplier 515 during placement.

The distal tip shape of the applier 515 can play a part in whether ornot the applier 515 penetrates certain tissues. For example, the scleralwall is a tougher tissue than the ciliary body or the iris root andgenerally requires a sharp-tipped applier in order to be penetrated. Thedistal tip of the applier 515 can be sharp enough to penetrate the irisroot or the ciliary body, but not so sharp (or sufficiently dull) so asnot to easily penetrate the inner wall of the sclera. The tip shape ofthe applier 515 can vary. The distal tip of the applier 515 describedherein can have a broad angle tip. The tip shape can be symmetricalrelative to a central, longitudinal axis of the applier, such as ahemispheric tip, blunt-tipped cone, rounded-off cone tip. The tip shapecan also be asymmetrical such as a shovel or spade shape tip. In anembodiment the applier 515 has a blunt tip. The blunt or atraumatic tipshape aids in the gentle dissection between tissues, such as the scleraand the ciliary body and the sclera and the choroid.

The distal tip of the applier 515 can also be coated to reduce frictionduring dissection. In an embodiment, the distal tip of the applier 515is coated with a hydrophilic coating such as HYDAK (Biocoat, Horsham,PA) or another slippery coating as is known in the art. A balance can bestruck between the angle of the distal tip, the angle of approach to thedissection entry point and whether or not the tip is covered by aslippery coating such that the risk of penetrating certain tissues (i.e.inner wall of the sclera) is reduced while the ability to penetrateother tissues (i.e. iris root or ciliary body) is maintained.

In addition to tip shape, coatings and pre-curvature of the applier 515,specific dissection performance also depends in part on the complianceand flexibility of the applier 515. The compliance and flexibility ofthe applier 515 is generally a function of the material, materialproperties and diameter of the material selected for the applier. Asmentioned above, it is desirable to have an applier 515 that does noteasily penetrate tissues such as the inner wall of the sclera. But it isalso desirable to have an applier 515 that can penetrate through othertissues such as the iris root or the ciliary body. Similarly, it isdesirable to have an applier 515 that can hug the curve of the innerscleral wall during blunt tissue dissection.

The outer diameter of the applier 515 can be selected and optimizedbased on the material and flexibility of the material used for theapplier 515. An applier made of nitinol, for example, can have an outerdiameter of about 0.009 inches. Nitinol is a superelastic metal that isquite bendable yet is stiff enough to be pushed through the iris rootand the ciliary body to reach to and hug the curve of the inner scleralwall during blunt dissection along the boundary between the sclera andthe adjacent tissues to the inner scleral wall. When combined with otherfeatures of the applier, for example a blunt tip, a nitinol applierhaving an outer diameter of about 0.009 inches can be used to gentlydissect the tissue layers while avoiding tunneling or piercing one orboth the inner scleral wall and choroid. Stainless steel spring wire isanother material that could be used for the applier 515. Stainless steelwire is generally slightly stiffer than nitinol. Thus, the outerdiameter of an applier made of stainless steel wire may need to besomewhat smaller than the outer diameter for an applier made of nitinolin order to achieve the same performance during blunt dissection. In anembodiment, the applier has an outer diameter of about 0.017 inches. Itshould be appreciated that for a given material's flexibility, theoptimum outer diameter of the applier can be determined and extrapolatedfor an applier of a different material having a different degree offlexibility. Other materials considered for the applier 515 includecompliant flexible wires made from a polymer or a polymer composite wirereinforced with high-strength fibers.

Methods of Implant Delivery

A method of delivering and implanting the implant into the eye is nowdescribed. In general, one or more implants 105 can be slidably mountedon and implanted in or near the suprachoroidal space using a deliverysystem as described herein. The mounting of the implant on the applierof the delivery system can be aided by a retention layer (or a retentioncoating on the applier or the internal walls of the implant) thatreversibly retains the implant on the tip of the applier while stillmaintaining a flexible and low profile applier as described above. Aretention layer can be used to avoid the implant from falling off theapplier inadvertently during delivery until the user actuates thedelivery component and effects controlled release of the implant fromthe applier 515, for example, upon proximal withdrawal of the applier515. The implant 105 is then secured in the eye so that it providesfluid communication between the anterior chamber and the suprachoroidalspace.

Implantation can be performed using a viewing lens as shown in FIG. 6G.A viewing lens 1405 (such as a gonioscopy lens represented schematicallyin FIG. 6G) is positioned adjacent the cornea. The viewing lens 1405enables viewing of internal regions of the eye, such as the scleral spurand scleral junction, from a location in front of the eye. The viewinglens 1405 can optionally include one or more guide channels 1410 thatare sized to receive the delivery portion 320 of the delivery system305. It should be appreciated that the locations and orientations of theguide channels 1410 in FIG. 6G are merely for illustration and that theactual locations and orientations can vary depending on the angle andlocation where the implant 105 is to be delivered. An operator can usethe viewing lens 1405 during delivery of the implant into the eye. Theviewing lens 1405 can have a shape or cutout that permits the surgeon touse the viewing lens 1405 in a manner that does not cover or impedeaccess to the corneal incision. Further, the viewing lens 1405 can actas a guide through which a delivery system 305 can be placed topredetermine the path of the device as it is inserted through thecornea.

An endoscope can also be used during delivery to aid in visualization.For example, a twenty-one to twenty-five gauge endoscope can be coupledto the implant during delivery such as by mounting the endoscope alongthe side of the implant or by mounting the endoscope coaxially withinthe implant. Ultrasonic guidance can be used as well using highresolution bio-microscopy, OCT and the like. Alternatively, a smallendoscope can be inserted though another limbal incision in the eye toimage the tissue during the procedure.

Each step of implantation can also be visualized using an internalvisualization system (see for example U.S. patent application Ser. No.12/492,085). Visualization can occur continuously during implantation orother procedures without the need for re-positioning or removing one ormore components of the imaging systems and without the need for viewingthrough a goniolens.

With reference to FIG. 7, the delivery portion 320 is positioned suchthat the distal tip of the applier 515 and the implant 105 penetratethrough a small, corneal incision to access the anterior chamber. Inthis regard, the single incision can be made in the eye, such as withinthe limbus of the cornea. In an embodiment, the incision is very closeto the limbus, such as either at the level of the limbus or within 2 mmof the limbus in the clear cornea. The applier 515 can be used to makethe incision or a separate cutting device can be used. For example, aknife-tipped device or diamond knife can be used to initially enter thecornea. A second device with a spatula tip can then be advanced over theknife tip wherein the plane of the spatula is positioned to coincidewith the dissection plane.

The corneal incision can have a size that is sufficient to permitpassage of the implant 105 on the applier 515 there through. In anembodiment, the incision is about 1 mm in size. In another embodiment,the incision is no greater than about 2.85 mm in size. In anotherembodiment, the incision is no greater than about 2.85 mm and is greaterthan about 1.5 mm. It has been observed that an incision of up to 2.85mm is a self-sealing incision. For clarity of illustration, the FIG. 7is not to scale.

After insertion through the incision, the applier 515 can be advancedinto the anterior chamber along a pathway that enables the implant 105to be delivered from the anterior chamber into the suprachoroidal space.With the applier 515 positioned for approach, the applier 515 can beadvanced further into the eye such that the blunt distal tip of theapplier 515 and/or the implant 105 penetrates the tissue at the angle ofthe eye, for example, the iris root or a region of the ciliary body orthe iris root part of the ciliary body near its tissue border with thescleral spur, to be discussed in more detail below.

The scleral spur is an anatomic landmark on the wall of the angle of theeye. The scleral spur is above the level of the iris but below the levelof the trabecular meshwork. In some eyes, the scleral spur can be maskedby the lower band of the pigmented trabecular meshwork and be directlybehind it. The applier can travel along a pathway that is toward theangle of the eye and the scleral spur such that the applier passes nearthe scleral spur on the way to the suprachoroidal space, but does notnecessarily penetrate the scleral spur during delivery. Rather, theapplier 515 can abut the scleral spur and move downward to dissect thetissue boundary between the sclera and the ciliary body, the dissectionentry point starting just below the scleral spur near the iris root IRor the iris root portion of the ciliary body. In another embodiment, thedelivery pathway of the implant intersects the scleral spur.

The applier 515 can approach the angle of the eye from the same side ofthe anterior chamber as the deployment location such that the applier515 does not have to be advanced across the iris. Alternately, theapplier 515 can approach the angle of the eye from across the anteriorchamber AC such that the applier 515 is advanced across the iris and/orthe anterior chamber toward the opposite angle of the eye. The applier515 can approach the angle of the eye along a variety of pathways. Theapplier 515 does not necessarily cross over the eye and does notintersect the center axis of the eye. In other words, the cornealincision and the location where the implant is implanted at the angle ofthe eye can be in the same quadrant when viewed looking toward the eyealong the optical axis. Also, the pathway of the implant from thecorneal incision to the angle of the eye ought not to pass through thecenterline of the eye to avoid interfering with the pupil.

FIG. 8 shows an enlarged view of the anterior region of the eye showingthe anterior chamber AC, the cornea C, the iris I, and the sclera S. Animplant 105 mounted on an applier 515 can approach the angle of the eyefrom the anterior chamber AC. As mentioned above, the applier 515 movesalong a pathway such that the dissection entry point of the distal tipof the applier 515 can penetrate the iris root IR or the iris rootportion of the ciliary body CB near the scleral spur SSp. Otherpenetration points near the angle of the eye are also considered herein.The surgeon can rotate or reposition the handle of the delivery devicein order to obtain a proper approach trajectory for the applier 515, asdescribed in further detail below.

The applier 515 with the implant 105 positioned thereupon can beadvanced through tissues near the angle of the eye, such as the irisroot IR, the ciliary body or the iris root portion of the ciliary body.As the applier 515 is advanced it can penetrate an area of fibrousattachment 805 between the scleral spur and the ciliary body. This areaof fibrous attachment 805 can be approximately 1 mm in length. Once thedistal tip of the applier 515 is urged past this fibrous attachmentregion 805, it then can more easily cause the sclera S to peel away orotherwise separate from the ciliary body and choroid as it follows theinner curve of the sclera A to form the suprachoroidal space SChS. Asdescribed above, a combination of the applier's tip shape, material,material properties, diameter, flexibility, compliance, coatings,pre-curvature etc. make it more inclined to follow an implantationpathway that mirrors the curvature of the inner wall of the sclera andbetween tissue layers such as the sclera S and choroid or the sclera andthe ciliary body.

The applier 515 can be continuously advanced into the eye, for exampleapproximately 6 mm. The dissection plane of the applier 515 can followthe curve of the inner scleral wall such that the implant 105 mounted onthe applier 515, for example after penetrating the iris root IR or theiris root portion of the ciliary body CB, can bluntly dissect theboundary between tissue layers of the scleral spur SSp and the ciliarybody CB such that a distal region of the implant 105 extends through thesupraciliary space SCiS and then, further on, is positioned between thetissue boundaries of the sclera and the choroid forming thesuprachoroidal space SChS.

Once properly positioned, the implant 105 can be released. The implant105 can be released for example by withdrawing the applier 515 such thatthe implant 105 is effectively pushed in a controlled manner off the tipof the delivery portion 320 with the sheath 510 (for example via themanner described above with reference to FIGS. 6A-6D). A retention layer512 can optionally be used to assist in retaining the implant 105 on theapplier 515 during the steps of delivery. However, the relationshipbetween the retention layer 512 and the implant 105 is readilyreversible such that the applier 515 and retention layer 512 can bewithdrawn into the sheath 510 to controllably release the implant 105from the tip of the applier upon arrival at the target location withinthe eye.

The implant 105 can include one or more structural features that aid toanchor or retain the implant 105 in the target region in the eye. Thestructural features can include flanges, protrusions, wings, tines, orprongs, and the like that can lodge into the surrounding eye anatomy toretain the implant 105 in place and prevent the implant 105 from movingfurther into the suprachoroidal space SChS. The structural features alsoprovide regions for areas of fibrous attachment between the implant 105and the surrounding eye anatomy. FIG. 9 illustrates schematically anapproximately 1 mm circumferential band 107 of the implant 105 near thejunction of the iris root and the scleral spur SSp along the inside ofthe scleral wall toward the back of the eye at which fibrous attachmentcan occur. Fibrous attachment can result, for example, from endothelialcell growth in, around and/or between retention features of the implant105. In addition, a small amount of scaring in and around an area offibrous tissue attachment between the scleral spur and the ciliary bodyin the region of the iris root portion of the ciliary body can providefor additional fixation to prop up the implant in its target location. Aproximal portion of the implant 105 can remain within the anteriorchamber AC. In one embodiment, at least 1 mm to 2 mm of the implant(along the length) remains in the anterior chamber.

The implant 105 can be positioned in the eye so that a portion of theimplant is sitting on top of the ciliary body CB. The ciliary body CBcan act as a platform off of which the implant 105 can cantilever intothe suprachoroidal space SChS. The implant 105 can have a relativestiffness such that, when implanted, the implant 105 deforms at least aportion of the tissue adjacent the suprachoroidal space to take on ashape that is different than the natural curvature. In this manner, theimplant 105 can lift or “tent” the sclera S outward such that thesuprachoroidal space SChS is formed around the distal end of the implant105. The tenting of the sclera S as shown in FIG. 9 has been exaggeratedfor clarity of illustration. It should be appreciated that the actualcontour of the tented region of tissue may differ in the actual anatomy.Whether the distal end of the implant 105 is positioned between thesclera and the ciliary body or the sclera and the choroid, the implant105 can act as a flow pathway between the anterior chamber AC and thesuprachoroidal space SChS without blockage of the outflow pathway bysurrounding tissues such as the sclera or the choroid.

The implant can also be positioned in the eye such that a portion of theimplant exerts a force or pressure on or against the ciliary body. Theimplant can exert a displacing force against the ciliary body such thatthe implant interferes with and/or resists the natural curvature of theciliary body. The implant can interfere with and locally change thecurvature of the boundary between the sclera and at least a portion ofthe ciliary body when implanted in the eye. As mentioned previously, theciliary body produces aqueous humor. The force exerted by the implant onthe ciliary body can decrease production of aqueous humor from ciliarybody. The stiff configuration of the implant 105 can push down orradially inward on the ciliary body

In an embodiment, an implant 505 can be an elongate, stiff shunt havingan internal lumen and an expanded and/or expandable region 510 (see,FIG. 10A-10D). The implant 505 can shunt aqueous from the anteriorchamber to the suprachoroidal space. The expandable region 510 of theimplant 505 can impart a pressure against the ciliary body CB such thataqueous production is reduced. The pressure can be in a downwarddirection or a radially inward direction on the ciliary body CB. In anembodiment, the pressure against the ciliary body CB causes at least aportion of the ciliary body CB to be displaced and aqueous productionreduced. In another embodiment, the implant does not displace theciliary body CB but simply exerts pressure against the ciliary body toreduce aqueous humor production. The combination of reduced aqueousproduction and the shunting of aqueous out of the anterior chamber canact in coordination to reduce pressure within the anterior chamber.

The implant 505 can be an elongated tubular member having a proximalend, a distal end, and a structure that permits flow of fluid (such asaqueous humor) along the length of the implant such as through or aroundthe implant from the anterior chamber. For example, the implant 505 canhave at least one internal lumen having at least one opening for ingressof fluid and at least one opening for egress of fluid. The implant 505need not include an internal lumen that fluidically communicates withthe anterior chamber AC. The implant 505 can be a solid bar that allowsfor flow of aqueous humor along an outside surface. The implant 505 canalso permit no flow of aqueous humor through or around the implant andinstead apply only a force on the ciliary body to reduce aqueous humorproduction.

The implant 505 can have a variety of shapes and configurations. Theimplant 505 can have a shape or take on a shape that optimizes theradial pressure exerted on the ciliary body CB. The implant 505 can beor include an inflatable balloon, expandable spacer or cage, or otherconfiguration. The implant 505 can have one or more expandable regionsof Hydrogel 510. The implant 505 can also have a variety ofcross-sections and shapes. For example, the implant can have a circular,oval, rectangular or star shape and can vary in cross-sectional shapemoving along its length. In an embodiment, the implant 505 can have astar or cross-shape such that aqueous from the anterior chamber flowsthrough one or more convoluted outer surface of the implant.

The pressure exerted by the implant 505 on the ciliary body CB can vary.In an embodiment, the implant 505 exerts a radially-inward (relative tothe center of the eye) force on the ciliary body CB. In anotherembodiment, the implant exerts a force that has a component that pointsradially inward and another component that does not pointradially-inward.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of an invention that is claimed orof what may be claimed, but rather as descriptions of features specificto particular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

1. An ocular implant, comprising: an elongate member having an internallumen forming a flow pathway, at least one inflow port communicatingwith the flow pathway, and at least one outflow port communicating withthe flow pathway, wherein the elongate member is adapted to bepositioned in the eye such that at least one inflow port communicateswith the anterior chamber, at least one outflow port communicates withthe suprachoroidal space to provide a fluid pathway between the anteriorchamber and the suprachoroidal space when the elongate member isimplanted in the eye; and a wall material imparting a stiffness to theelongate member, wherein the stiffness is selected such that afterimplantation the elongate member deforms eye tissue surrounding thesuprachoroidal space forming a tented volume.
 2. The implant of claim 1,wherein the stiffness of the elongate member is greater than a stiffnessof the eye tissue surrounding the suprachoroidal space.
 3. The implantof claim 1, wherein the elongate member forms a chord relative to acurvature of the suprachoroidal space.
 4. The implant of claim 1,wherein the eye tissue surrounding the suprachoroidal space comprises anouter tissue shell having a first boundary and a first curvature and aninner tissue shell having a second boundary and a second curvature,wherein the first curvature and the second curvature form a ratio. 5.The implant of claim 4, wherein the stiffness of the elongate memberchanges the ratio between the first curvature and the second curvature.6. The implant of claim 4, wherein the elongate member is curved suchthat it intersects, but does not conform to the first or secondcurvatures when implanted.
 7. The implant of claim 1, wherein the wallmaterial has a Young's modulus that is less than 30,000 pounds persquare inch.
 8. The implant of claim 1, wherein the wall material has aYoung's modulus that is between about 30,000 pounds per square inch and70,000 pounds per square inch.
 9. The implant of claim 1, wherein thewall material has a Young's modulus that is approximately 200,000 poundsper square inch.
 10. The implant of claim 1, wherein the wall materialhas a Young's modulus that is less than or equal to 40,000,000 poundsper square inch.
 11. The implant of claim 1, wherein the elongate memberhas an inner diameter of about 0.012 inch and an outer diameter of about0.015 inch.
 12. The implant of claim 1, wherein the elongate member hasa length in the range of about 0.250 inch to about 0.300 inch.
 13. Amethod of implanting an ocular device into the eye, comprising: formingan incision in the cornea of the eye; loading onto a delivery device animplant having a fluid passageway and a wall material imparting astiffness to the implant; inserting the implant loaded on the deliverydevice through the incision into the anterior chamber of the eye;passing the implant along a pathway from the anterior chamber into thesuprachoroidal space; positioning at least a portion of the implant inthe suprachoroidal space such that a first portion of the fluidpassageway communicates with the anterior chamber and a second portionof the fluid passageway communicates with the suprachoroidal space toprovide a fluid passageway between the suprachoroidal space and theanterior chamber; and releasing the implant from the delivery devicesuch that the implant achieves a predetermined shape within thesuprachoroidal space and forms a chord relative to a curvature of thesuprachoroidal space.
 14. The method of claim 13, wherein the chord isstraight.
 15. The method of claim 13, wherein the chord is curved. 16.The method of claim 13, wherein the stiffness of the implant is greaterthan a stiffness of adjacent eye tissue.
 17. A method of treating aneye, comprising: forming an incision in the cornea of the eye; insertingan implant through the incision into the anterior chamber of the eyewherein the implant includes a fluid passageway; passing the implantalong a pathway from the anterior chamber into the suprachoroidal space;positioning the implant such that a first portion of the fluidpassageway communicates with the anterior chamber and a second portionof the fluid passageway communicates with the suprachoroidal space toprovide a fluid passageway between the suprachoroidal space and theanterior chamber; and applying a force on the ciliary body with theimplant so as to reduce aqueous outflow from the ciliary body.
 18. Themethod of claim 17, wherein applying a force on the ciliary body withthe implant elicits an increase in prostaglandin production by theciliary body.
 19. The method of claim 17, wherein applying a force onthe ciliary body with the implant comprises displacing at least aportion of the ciliary body.
 20. The method of claim 17, whereinapplying a force on the ciliary body with the implant does not displacethe ciliary body.